SOTRET Drug Patent Profile
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When do Sotret patents expire, and what generic alternatives are available?
Sotret is a drug marketed by Sun Pharm Inds Ltd and is included in two NDAs.
The generic ingredient in SOTRET is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sotret
A generic version of SOTRET was approved as isotretinoin by AMNEAL PHARMS NY on September 29th, 2017.
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Questions you can ask:
- What is the 5 year forecast for SOTRET?
- What are the global sales for SOTRET?
- What is Average Wholesale Price for SOTRET?
Summary for SOTRET
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 73 |
Clinical Trials: | 21 |
Patent Applications: | 7,499 |
Formulation / Manufacturing: | see details |
DailyMed Link: | SOTRET at DailyMed |
![SOTRET drug patent expirations Drug patent expirations by year for SOTRET](/p/graph/s/t/SOTRET-patent-expirations.png)
Recent Clinical Trials for SOTRET
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Children's Oncology Group | Phase 2 |
Children's Oncology Group | N/A |
National Cancer Institute (NCI) | N/A |
US Patents and Regulatory Information for SOTRET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Inds Ltd | SOTRET | isotretinoin | CAPSULE;ORAL | 076041-001 | Dec 24, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm Inds Ltd | SOTRET | isotretinoin | CAPSULE;ORAL | 076041-003 | Dec 24, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm Inds Ltd | SOTRET | isotretinoin | CAPSULE;ORAL | 076041-002 | Dec 24, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sun Pharm Inds Ltd | SOTRET | isotretinoin | CAPSULE;ORAL | 076503-001 | Jun 20, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |